{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA209452"
        ],
        "brand_name": [
          "JAVYGTOR"
        ],
        "generic_name": [
          "SAPROPTERIN DIHYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Dr. Reddys Laboratories Inc"
        ],
        "product_ndc": [
          "43598-097"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SAPROPTERIN DIHYDROCHLORIDE"
        ],
        "rxcui": [
          "1111018",
          "2611951"
        ],
        "spl_id": [
          "f6a11439-21eb-fc03-1869-6960d7cf8791"
        ],
        "spl_set_id": [
          "1590afa1-baa4-70e5-5a3b-468401c71044"
        ],
        "package_ndc": [
          "43598-097-11",
          "43598-097-30"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "RG277LF5B3"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94369",
      "recalling_firm": "Dr. Reddy's Laboratories, Inc.",
      "address_1": "107 College Rd E",
      "address_2": "N/A",
      "postal_code": "08540-6623",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0485-2024",
      "product_description": "Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-097-30.",
      "product_quantity": "17,332 cartons",
      "reason_for_recall": "Sub-potent Drug; powder discoloration associated with decreased potency",
      "recall_initiation_date": "20240408",
      "center_classification_date": "20240506",
      "report_date": "20240515",
      "code_info": "Lot #: T2202812, Exp. 07/31/2025; T2204053, Exp. 10/31/2025; T2300975, T2300976, Exp. 02/28/2026; T2304356, Exp. 08/31/2026."
    }
  ]
}